3D printing regulation: should governments intervene?

From guns to body parts,3D printing technology has introduced a digital manufacturing revolution, which is already disrupting some of our well-established industries.

Companies are now able to print silicone, latex, ceramic, clay, play dough, Nutella, or icing sugar. In the medical field, 3D printing brings the ability to print replacement body parts, organs, skin and bones. NASA has recently purchased a 3D printer for the International Space Station in order to produce spare parts and other items, cutting transportation costs and improving safety. In China, a company has used large 3D printers to build 10 detached one-storey houses in just a day. However, technology is advancing faster than regulation. Very soon, regulators will need to consider the implications of the recent emergence of 4D printing.

A disruptive innovation…

3D printing technology (also known as additive layer manufacturing) will bring about substantial changes to the manufacturing, medical, military, education, shipping, and many other industries and fields. One of the biggest and more apparent changes will be the mass-customisation of goods in order to satisfy the needs of the individual customer. This will drastically reduce manufacturing costs, which will in turn have an effect on the international division of labour. We may therefore see an increasing number of Western companies leave Asian production facilities in order to start manufacturing their own goods. Additionally, the shipping industry will also need to adapt to the changing environment.

In the last year, we have seen the emergence of 4D printing, which under the concept of “self-assembly” is a process that can build an ordered structure without human interaction. This is a potential revolution that will start by disrupting the manufacturing, construction and infrastructure industries. For instance, imagine water pipes that can assemble themselves and adapt to changes in water pressure and temperature.

...with considerable risks and challenges

As the industry matures, regulators will need to address the risks and challenges that this technology inevitably brings; issues such as the protection of intellectual property, consumer and public safety, infrastructure, taxes, etc.

3D printed guns have illustrated the public safety and security risks of this technology; but there are also health-related risks, such as the 3D printing of food and other materials; or even ethical issues due to the 3D printing of body parts or organs, especially if they promote unhealthy lifestyles or are used for testing purposes.

Much has also been reported on the implications of such technology for intellectual property protection, particularly with regard to design rights, trademarks, copyright, and patents. A future challenge might be the agreement on the standards, common regulatory frameworks, and enforcement processes across borders. The World Intellectual Property Organisation (WIPO) has acknowledged implications for manufacturing capacities throughout the world, but has not made any regulatory recommendations thus far.

Similarly, issues with personal data, which are used for the customisation of goods, will need to be addressed.

In the medical field, the public and private sector will need to ensure the availability of 3D printed medical devices, which may in turn have consequences on the social security systems of countries and regions. On the supply side, it will be critical to secure the access and amount of suitable materials used for 3D printing, as there are currently only a handful of companies in this space. In the labour market, the industry may also face a shortage of qualified workers in the near future.

It is critical to address these issues as the industry moves towards a more mainstream market. In order for it to flourish, lower prices, higher functionality and an improved ease of use will be required; but favourable conditions can only be created if regulation contemplates the risks and challenges mentioned above.

To regulate or not to regulate

There are inherent risks and challenges to 3D printing technology, but it is unlikely that regulators around the world will decide to fully regulate the sector until there is a 3D printer in every household.

Governments have generally started addressing the potential regulation of 3D printing technology amid fears triggered by 3D printed guns. In the United States, under the Undetectable Firearms Act, it is now illegal to manufacture firearms which cannot be detected by a metal detector. The Act was extended for 10 years in December 2013. In the United Kingdom, the UK Home Office revised its firearms policy in November 2013 to include language that made the manufacture, sale, and possession of 3D guns illegal.

In the European Union, several MEPs have recently addressed the risks of 3D printed guns. The obligations for the manufacture or acquisition of weapons by private individuals are regulated under the Firearms Directive. The European Commission has also said that consultations with experts have taken place, and that possible vulnerabilities will be considered in the evaluation report on the Firearms Directive scheduled for 2015, which may lead to amending proposals of such Directive.

The implications for intellectual property have also been addressed by some governments. In the UK, the Intellectual Property Act which will come into force in the autumn has aimed to create new protections and introduced a number of key policy changes, including the creation of a criminal sanction for intentional copying of a registered design; helping businesses assess their IP before undertaking costly and lengthy legal proceedings; or the ability of the UK Intellectual Property Office of sharing information on unpublished patent applications with other national patent offices.

It would perhaps be important to remind ourselves of a statement made by the WIPO, “the need to balance these interests – ensuring that incentives and rewards are in place for those who invest in new ideas, without stifling innovation and openness in the use of online design – will be a key challenge for IP policymakers going forward.”

The opportunity for self-regulation

Regulatory standards for parts, processes and safety that apply to 3D printers, materials, or digital software used, need to be created and enforced in order to protect the safety of consumers. Sooner or later, governments and regulators will address other misuses of 3D printing rather than the dangers of 3D printed guns or the implications for intellectual property. However, there is generally a lack of knowledge among policy-makers about the great potential and repercussions of this technology.

But without regulatory intervention, in the long-term there may be a lack of public trust, lack of resources and materials, as well as high barriers to market entry. In this sense, the 3D printing industry has at present the opportunity of engaging with governments and giving them the necessary technical information in order to set the basic standards to regulate the sector, which would pave the way for long-term innovation in this field.